EMA Advises Pharma Companies on Drug Authorization Shift Post-Brexit

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 05-04-2017 09:57


The European Medicines Agency (EMA) has notified marketing authorization holders (MAHs) to prepare for drug authorization shifts of centrally authorized medicinal products in the wake of the UK’s withdrawal from the European Union (EU) (Brexit).

The EMA pointed out that EU law requires that MAHs for centrally authorized medicinal products be established in the EU or the European Economic Area (EEA), which includes Iceland, Liechtenstein, and Norway. Some MAH activities, such as pharmacovigilance and batch release, must also be performed in the EU or EEA. To that end, MAHs may be required to adapt processes and to consider changes to the terms of the marketing authorization in order to ensure its continuous validity and use once the Brexit process is complete.

The EMA cautions that MAHs will need to act sufficiently in advance to avoid any impact on the continuous supply of medicines within the EU. In particular, the European Commission and the EMA expect MAHs to prepare and proactively screen authorizations they hold for the need for any changes. Any necessary transfer or variation requests will need to be submitted to the agency in due time considering the procedural timelines foreseen in the regulatory framework.

EMA officials have also met with the heads of the National Competent Authorities of the EU/EEA member states to begin discussion on how to share the workload related to evaluating and monitoring medicines among member states without the UK after its withdrawal.

Source: European Medicines Agency


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